A prospective evaluation of the fourth national Be Clear on Cancer ‘Blood in Pee’ campaign in England

Abstract Objective To assess the impact of the fourth Be Clear on Cancer (BCoC) ‘Blood in Pee’ (BiP) campaign (July to September 2018) on bladder and kidney cancer symptom awareness and outcomes in England. Methods In this uncontrolled before and after study, symptom awareness and reported barriers to GP attendance were assessed using panel and one‐to‐one interviews. The Health Improvement Network (THIN), National Cancer Registration and Analysis Service (NCRAS) and NHS Cancer Waiting Times (CWT) data were analysed to assess the impact on GP attendances, urgent cancer referrals, cancer diagnoses and 1‐year survival. Analyses used Poisson, negative binomial and Cox regression. Results Symptom awareness and intention to consult a GP after one episode of haematuria increased following the campaign. GP attendance with haematuria (rate ratio (RR) 1.17, 95% confidence interval (CI): 1.07–1.28) and urgent cancer referrals (RR 1.18 95% CI: 1.08–1.28) increased following the campaign. Early‐stage diagnoses increased for bladder cancer (difference in percentage 2.8%, 95% CI: −0.2%–5.8%), but not for kidney cancer (difference −0.6%, 95% CI: −3.2%–2.1%). Conclusions The fourth BCoC BiP campaign appears to have been effective in increasing bladder cancer symptom awareness and GP attendances, although long‐term impacts are unclear.

cancer incidence in the United Kingdom increased by 86.4% from 1993 to 2017, more so amongst females. Males have a similar incidence of kidney cancer (28 cases per 100,000) as for bladder cancer, although females have a higher incidence of kidney cancer (15 per 100,000) (Cancer Research UK, 2020). Age-standardised 5-year survival is similar for bladder (52.6%) and kidney (63.8%) cancers (ONS, 2020a(ONS, , 2020b. Haematuria, or blood in the urine, is a common high-risk symptom of urological cancer, particularly bladder cancer. Haematuria can be visible to patients (macroscopic) or only detectable with a urine dipstick test (microscopic). Macroscopic haematuria is the most common symptom that patients with bladder cancer report to primary care prior to diagnosis, accounting for over half of all presentations (Shephard et al., 2012). Macroscopic haematuria is also the most common symptom of kidney cancer (reported by 17.7%), with other common presenting symptoms being much less specific (i.e. back pain, abdominal pain and fatigue) (Shephard et al., 2013). In England in 2017, 69.4% of patients with a new diagnosis of bladder cancer and 58.9% of new kidney cancer cases were diagnosed following a referral from their GP after reporting symptoms (National Cancer Intelligence Network, 2020).
Cancer symptom awareness starts with a person recognising a bodily change and then appraising the symptom to decide on seriousness. Individuals who are worried about their symptoms then consult a healthcare professional, most often a GP in the United Kingdom . Prompt presentation with potential cancer symptoms is important for the early diagnosis of cancer; however, 25.8% of patients with bladder cancer and 30.1% of kidney cancer patients with symptoms took longer than 14 days to present to their GP (Keeble et al., 2014). Cancer symptom awareness in the United Kingdom is lower amongst individuals under 35 or over 74 years of age, males, single people, the unemployed and those from areas of high deprivation (Forbes et al., 2014;McCutchan et al., 2015;Niksic et al., 2015).
Lower cancer symptom awareness and higher perceived barriers to accessing healthcare for symptomatic patients are both associated with lower cancer survival Niksic et al., 2016).
Fear and fatalistic beliefs relating to cancer can delay presentation with such symptoms, particularly in deprived populations (McCutchan et al., 2015;Niksic et al., 2015).
The Be Clear on Cancer (BCoC) programme, led by Public Health England (PHE), delivers campaigns that aim to improve the early diagnosis of cancer by raising public awareness of symptoms and signs of cancer and encouraging people to attend their GP without delay (Public Health England, 2020). To date there have been four BCoC 'Blood in Pee' (BiP) campaigns focusing on raising awareness of symptoms of bladder or kidney cancer. These campaigns were delivered through a variety of media in England, predominantly targeting those aged over 50 years of age and those from lower socio-economic groups. For example, TV advertising was bought in programmes popular with those aged over 50 from lower socio-economic groups. An evaluation report by PHE of the pilot campaigns and the first three national BCoC BiP campaigns has been published online (Kockelbergh, 2020), which showed mixed results. There was an increase in GP presentations, referrals and cancers diagnosed, but no clear impact on stage at diagnosis or 1-year survival. The aim of this study was to assess independently the impact of the fourth BCoC 'BiP' campaign on bladder and kidney cancer symptom awareness and outcomes. A secondary aim was to explore the long-term trends in bladder and kidney cancer diagnoses in the context of the four BCoC BiP campaigns.

Reporting of this study has been guided by the Strengthening The
Reporting of Observational Studies in Epidemiology (STROBE) statement (von Elm et al., 2007). A completed STROBE checklist can be found in the Supporting Information.

| Campaign overview
The fourth national BiP campaign ran from 19 July 2018 to 16 September 2018 in England. The aim of the campaign was to raise awareness of symptoms of bladder and kidney cancer and encourage patients with these symptoms to present to their GP to facilitate earlier diagnosis. The campaign ran under the 'Be Clear on Cancer' brand with the core message: If you notice blood in your pee, even if it's 'just the once', tell your doctor. Channels used to deliver the campaign included TV, radio, press and out of home (in public toilets in shopping centres, bars and motorway service stations) advertising; digital advertising through Facebook and search engines; public relations activities by PHE; and working with partners including cancer charities and community organisations.
There was also activity targeted at those aged 50 and over from Black and South Asian audiences. This included TV, radio and public toilet advertising; public relations; partnership activity; and outreach events.

| Data collection and variables
This study utilised an uncontrolled before and after study design. Data were analysed for a range of variables (herein 'metrics') spanning the patient pathway for bladder and kidney cancer diagnosis. The 'analysis period' was the time period during and shortly after the campaign and varied for each metric to take into account when an impact of the campaign would be expected (i.e. attendance at a GP is expected to occur more quickly than a diagnosis of cancer). The comparison period was the same time period during the previous year, 2017, thereby reducing risk of seasonal effects on metrics (see Table 1 (Lai et al., 2020) and adapted for the fourth BCoC BiP campaign (see Supporting Information). Data collection was performed using questionnaires delivered online or in-person using tablet computers. Precampaign data collection occurred from 22 June to 1 July 2018, and post-campaign data collection occurred between 21 and 30 September 2018.

| GP attendances
Data on GP attendances for visible blood in pee (macroscopic haematuria) were sourced from The Health Improvement Network (THIN) database (THIN, 2020). This is a primary care database containing anonymised copies of GP records from approximately 6% of the UK population. Consultation data were grouped into weeks and adjusted to account for bank holidays. Information on the number of GP practices submitting data each week (which decreased from 177 to 116 practices over the period considered) was also collected to enable the calculation of the average number of attendances per practice per week.
2.2.3 | Urgent cancer referrals for suspected urological cancer (two-week-wait [TWW] referrals) and cancers diagnosed from an urgent cancer referral Data on urgent cancer referrals for suspected urological cancer and cancer diagnoses that resulted from an urgent cancer referral were collected from the National Cancer Waiting Times Monitoring Data Set, provided by NHS England. The data were grouped according to the month the patient was first seen. Cancers were defined using ICD-10 as bladder (C67), kidney and urinary tract (C64-C66 and C68) and urological (including prostate) (C60-C61 and C63-68).

| Emergency cancer diagnoses
Monthly data on the number of emergency cancer diagnoses were sourced from the Hospital Episodes Statistics (HES) Admitted Patient Care data linked to cancer registration data held by the National Cancer Registration and Analysis Service (NCRAS) (NCRAS, 2020b) using methodology outlined in NCRAS Official Statistics Emergency Presentation metric (NCRAS, 2020a). Cancers were defined using ICD-10 as bladder (C67), kidney and urinary tract (C64-C66 and C68).

| Cancer diagnoses in the Cancer Waiting Times (CWT) database
Data on the number of urological cancer diagnoses in the Cancer Waiting Times (CWT) database from all routes to diagnosis were sourced from the National Cancer Waiting Times Monitoring Data Set, provided by NHS England. The data were grouped according to the month the patient was first treated. Cancers were defined using T A B L E 1 Analysis and comparison periods used in the analysis for each metric ICD-10 as bladder (C67), kidney and urinary tract (C64-C66 and C68) and urological (including prostate) (C60-C61 and C63-68).

| Cancers diagnosed and stage at diagnosis
Data on the number of bladder and kidney cancers diagnosed and the stage at diagnosis were sourced from the National Cancer Registration Dataset collected by NCRAS (Henson et al., 2020). The data were again grouped into weeks and adjusted to account for bank holidays.

| Statistical analysis
For survey questions relating to symptom awareness and intended action, the percentage of respondents who chose the response option, or set of options, that were the target of the campaign (i.e. indicated symptom awareness and correct intended actions) were compared between surveys conducted in the periods before and after the campaign. Comparisons used the two sample test of proportions.
Responses were weighted using the Random Iterative Method (RIM) according to age, gender and SES, and a continuity correction was applied.
Metrics which included either weekly or monthly counts (all except early stage at diagnosis and survival) were analysed using Poisson regression or negative binomial regression with one explanatory variable coded as 0 or 1 for the comparison and analysis period.
Results are presented as the total count in each period, plus the esti-

| Ethics statement
All data used in this study were acquired from external sources, none

| GP attendances
The rate of GP attendances for haematuria was 17% higher during the analysis period relative to the comparison period (estimated RR 1.17, 95% confidence interval (CI): 1.07 to 1.28) (see Table 4). This increase was driven by males, for whom there was a 24% increase during the analysis period compared to the comparison period (RR 1.24, 95% CI: 1.11-1.40) (see Table S2). Figure 1 shows the long-term trends for GP presentations with haematuria, which demonstrates an increase 0.92-1.11), although longer-term trends suggest an increase in bladder cancer diagnoses from the first three campaigns (see Figure 3).
The numbers of urological cancers (including prostate and rarer urological cancer types) diagnosed from urgent referral were 13% higher in the analysis period, relative to the comparison period (RR 1.13, 95% CI: 1.03-1.24), with a much more pronounced increase in urological cancer diagnoses for Months 3-5 of 2018 (a few months prior to the fourth campaign).

| Emergency cancer diagnoses
There was some indication of a reduction in the percentage of bladder cancer diagnoses referred by a GP as an emergency (difference [analysis À comparison] À1.1%, 95% CI: À2.1% to À0.1%), but no change for kidney cancers between the analysis and comparison periods. These findings are in the context of a long-term trend of reducing emergency diagnosis of urological cancers (see Figure S1).

| Cancer diagnoses in the CWT database
There was no evidence of a difference in bladder cancer and kidney and urinary tract cancer diagnoses in the CWT database between the analysis and comparison period (bladder: RR 0.99, 95% CI: 0.92-1.07; kidney and urinary tract: RR 1.01, 95% CI: 0.92-1.11). There was an increase in urological cancer diagnoses in the CWT database in the analysis period, relative to the comparison period (RR 1.13, 95% CI: 1.06-1.21), with a marked upsurge relative to the slightly upward background trend before and after the fourth campaign (see Figure S2).

| Cancer diagnoses in the National Cancer Registration Dataset
The number of bladder carcinoma in situ diagnosed according to the National Cancer Registration Dataset was 11% higher in the analysis period relative to the comparison period (RR 1.11, 95% CI: 1.05-1.17).
However, there was little evidence of differences in the diagnosis of malignant bladder cancer (RR 0.97, 95% CI: 0.92-1.02), kidney and urinary tract cancer (RR 1.00, 95% CI: 0.95-1.05) or non-invasive papillary carcinoma of the bladder (RR 1.00, 95% CI: 0.83-1.19). There were also no clear departures from the underlying trends, although this could have been masked by week to week variability (see Figure S3).

| Early stage at diagnosis
There was a small, statistically non-significant (p = 0.07) increase in  Figure S4).

| Diagnostics in secondary care
The number of ultrasounds, CT and MRI of the bladder and kidney was 10% higher in the analysis period, relative to the comparison period (RR 1.10, 95% CI: 1.06-1.14). There has been an upward trajectory in diagnostic activity in this area from 2012 to 2018 (see Figure S5).

| Survival
The was some evidence of improved survival within 1 year for those diagnosed with bladder cancer in the analysis period, relative to the

| Comparison with existing literature
The results of the evaluation of the fourth BCoC BiP campaign are consistent with the PHE report on the first three national campaigns (Kockelbergh, 2020

| Implications for policy and practice
Raising cancer symptom awareness and reducing barriers for GP attendances with symptoms potentially linked to an undiagnosed cancer has been one area of focus aimed at addressing the UK's relatively lower cancer survival compared to other high-income countries  and thus achieving the NHS England aim of earlystage cancer diagnosis for 75% of patients by 2028 (NHS, 2019). The BCoC BiP campaign appears to be effective in increasing symptom awareness for bladder and kidney cancer and subsequent GP presentations in this and previous evaluations (Kockelbergh, 2020), in line with the effect of BCoC campaigns on other cancer types (Lai et al., 2020). Increased urgent suspected cancer referrals have been shown to reduce overall mortality and increase the rates of earlystage cancer diagnosis (Round et al., 2020), which would suggest that

| CONCLUSIONS
The fourth BCoC BiP campaign appears to have achieved its main aim of raising awareness of the importance of the symptoms of bladder and kidney cancer amongst the public and encouraging them to present to their GP. Downstream data show an increase in GP attendances and urgent cancer referral activity in the short-term. It is unclear whether these more direct campaign effects impact on bladder and kidney cancer diagnoses, including early-stage cancer diagnoses or whether changes observed are the result of long-term trends in cancer incidence and survival.